MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR MODULAR FEMORAL NECK; HIP COMPONENT

Model Number PHA01244

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 04/01/2020

Event Type  Injury  

Manufacturer Narrative

This event will be updated once the investigation is complete.Trends will be evaluated.

Event Description

Allegedly, patient felt something clunk or move, took one more step, felt a severe jolt in his groin and fell.X rays showed a right femoral neck fracture at the junction of the femoral stem component with the femoral neck.Records state the fracture caused dislocation and displacement of his hip joint.The fracture was in the femoral neck/stem modular junction.

• Brand Name: PROFEMUR MODULAR FEMORAL NECK
• Type of Device: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer (Section G): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 10864720
• MDR Text Key: 217091665
• Report Number: 3010536692-2020-00700
• Device Sequence Number: 1
• Product Code: LWJ
• UDI-Device Identifier: M684PHA012441
• UDI-Public: M684PHA012441
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 01/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: PHA01244
• Device Catalogue Number: PHA01244
• Device Lot Number: S04105358X1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/28/2020
• Date Manufacturer Received: 10/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Removal/Correction Number: Z-2941-2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention